NCT06382623

Brief Summary

The aim of the study is to compare the effectiveness of peritendinous steroid injection under ultrasound guidance and percutaneous A1 pulley release procedures in terms of disease stage, pain, and severity of locking in patients with trigger finger.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

9 months

First QC Date

April 8, 2024

Last Update Submit

June 5, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stage of the disease

    Modified Quinnel classification Stage 1: Normal movement, no pain. * Stage 2: Normal movement, occasional pain. * Stage 3: Irregular movement (catching without crepitus or locking). * Stage 4: Locking present, actively correctable. * Stage 5: Locking present, passively correctable.

    first week, first mount, third month

Secondary Outcomes (2)

  • Pain intensity

    first week, first month, third month

  • severity of triggering

    first week, first month, third month

Study Arms (2)

The peritendinous steroid group

A 1 ml mixture of corticosteroid (2 mg + 5 mg/ml betamethasone) and 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected peritendinously between the A1 pulley and the flexor tendon sheath at the metacarpophalangeal joint level under ultrasound guidance.

Other: The peritendinous Betamethasone group

The percutaneous A1 pulley release group

In the A1 pulley release group, 1 ml of local anesthetic agent (20 ml 2% prilocaine) was injected into the pulley-associated subcutaneous tissue using a 27 G needle under ultrasound guidance. The metacarpophalangeal joint was brought into slight hyperextension. Subsequently, a 20 G 0.9x38mm needle, modified by bending approximately 40-45 degrees from the proximal 1/3 of the needle with the aid of a cap, was used. The needle was advanced in-plane from distal to proximal along the midline, with simultaneous movement towards the palmar surface, aiming to cut or loosen the pulley between the tendon and A1 pulley. The loosening procedure was repeated from the distal to proximal aspect of the pulley until the sensation of resistance at the needle tip disappeared.

Procedure: The percutaneous A1 pulley release

Interventions

Ultrasound-guided percutaneous pulley release is a procedure aimed at loosening the pulley using various cutting instruments or hypodermic needles under ultrasound guidance.

The percutaneous A1 pulley release group

USG-guided injection of corticosteroid between the A1 pulley and the flexor tendon sheath.

The peritendinous steroid group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

older 18 ages

You may qualify if:

  • Being over 18 years of age
  • Having had trigger finger complaints for more than 1 month
  • Not having received any injections for trigger finger diagnosis within the last 1 month
  • Signing the informed consent form indicating willingness to participate in the study

You may not qualify if:

  • Refusing to participate in the study
  • Presence of partial or complete tendon rupture in the relevant tendon of the finger to be treated
  • Presence of wounds and infection in the area where the procedure will be performed
  • Pregnancy status
  • History of allergy to the injected medications (local anesthetic, steroid)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Trigger Finger Disorder

Condition Hierarchy (Ancestors)

Tendon EntrapmentTendinopathyMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • zeliha gizem mac, MD

    university of health sciences, Department of PM&R

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

April 8, 2024

First Posted

April 24, 2024

Study Start

October 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations